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The FINESSE trial was a randomized, double-blind study comparing three treatment strategies in 2,452 patients with STEMI undergoing PCI: abciximab plus half-dose reteplase, abciximab alone, or placebo. While the primary endpoint—death or complications of MI—showed no significant differences among the groups by 90 days, there was a notable increase in bleeding events in the combination therapy group. These findings suggest that although facilitated PCI with abciximab and reteplase did not improve mortality or complications, it did elevate bleeding risk.
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FINESSE Trial Design: FINESSE was a randomized, double-blind trial ofabciximab with half-dose of the thrombolytic reteplase (n = 828), abciximab alone (n = 818), or placebo (n = 806) in patients undergoing PCI for STEMI. All patients received IV infusion of abciximab in the cath lab and continued for 12 hours. Primary endpoint was death or complications of MI (cardiogenic shock, heart failure, or resuscitated ventricular fibrillation) by 90 days. • Results • Upon arrival at the cath lab, more patients in reteplase + abciximab arm had open artery prior to PCI (61%) vs. abciximab group (26%; p < 0.001) or placebo group (25%; p < 0.001) • No difference in primary endpoint of death or complications of MI between the three groups (Figure) • TIMI major or minor bleeding through discharge or day 7 ↑ in combination facilitated PCI arm (14.5%) vs. either abciximab facilitated PCI arm (10.1%; p = 0.008) or placebo primary PCI group (6.9%; p < 0.001) • Conclusions • Among patients undergoing PCI for STEMI, there was no difference in frequency of death or complications of MI by 90 days when comparing facilitated PCI strategy of abciximab and half-dose thrombolytic (reteplase), facilitated PCI strategy with abciximab alone, or placebo with primary PCI • However, both facilitated PCI strategies were associated with increased risk of bleeding Death or Complications of MI by 90 Days p = NS % Reteplase + Abciximab + Facilitated PCI Placebo + Primary PCI Abciximab + Facilitated PCI Presented at ESC 2007